This English-taught, interdisciplinary postgraduate programme brings together pharmacy, law and medicine to provide an international academic education focused on regulatory affairs. The curriculum is practice-oriented and keeps pace with current regulatory challenges, covering topics such as medicinal products and medical devices, life-cycle management, quality–safety–efficacy, document management, market access and regulatory decision-making.
You will be trained across a broad spectrum of regulatory science and healthcare subjects, learning how scientific and regulatory expertise can generate additional value for patients, healthcare systems and society. Teaching is delivered by a dedicated team of experts and lecturers, and the programme deliberately connects you with more than 100 experienced professionals from health authorities, pharmaceutical companies, industry associations and academia—offering strong networking and professional-development opportunities.
The programme structure (Modules 1–12) supports the expansion of your regulatory knowledge and practical skills, helping to accelerate your career in regulatory affairs and related fields. Successful completion awards the academic degree Master of Drug Regulatory Affairs (MDRA.), reflecting the course’s focus on applied, interdisciplinary competence.
Requirements / key facts
This two-year full-time Master's is structured over four semesters (or three years / six semesters for the part-time option) and combines blended learning with a strong practical focus. Course delivery is split between on-campus sessions in Bonn (about 20%) and online teaching (around 80%), making the programme well suited to students who need flexibility while still benefiting from some face-to-face interaction. Instruction and assessment are conducted in English.
The curriculum comprises 12 modules in total. To pass the programme students must complete written study papers or project work in six modules and sit either oral or written examinations in the other six. Practical application of classroom learning is reinforced through a compulsory internship, and the degree is completed with a Master’s thesis that synthesises the student’s knowledge and research or project outcomes. Taken together, these components ensure consolidation of theoretical knowledge, development of practical skills, and the ability to present and defend independent work.
Key structural features and expected learning outcomes (summary)
This design supports the development of analytical and practical competencies through a mix of coursework, assessed projects, workplace experience and independent research—preparing graduates to apply their learning in professional regulatory environments.
You must hold a professionally qualifying university degree in a relevant life-science field and have practical work experience. The examination board assesses whether degrees outside the listed subjects are equivalent and acceptable. International applicants should expect to document both their academic credentials and their professional experience; if your degree was earned abroad, allow time for any required translations or formal recognition.
Professional experience must amount to at least one year and should be directly related to the subject of your qualifying degree (for example, work in industry, clinical settings, research labs, regulatory roles, or other relevant positions). To avoid delays, prepare clear employment evidence (employment contracts or reference letters that state job title, duties and exact dates). If you are unsure whether your background qualifies, contact the examination board or admissions office early for guidance.
Admission requirements (concise)
Winter Semester (International)
Application deadlineIn spring for the following winter semester
Graduates are prepared for careers in regulatory affairs across pharmaceutical and medical device industries, health authorities, regulatory consulting, market access teams, quality and safety departments, and industry associations. The programme’s mix of regulatory science, document management and lifecycle knowledge equips students for roles such as regulatory affairs specialist/manager, submission manager, regulatory consultant, and positions in regulatory policy and compliance.
Because the programme is international in orientation and includes comparisons and content related to global regulatory contexts, graduates can pursue opportunities both within national authorities and multinational companies. The compulsory internship and strong practitioner network further support transition into sector roles and professional advancement in regulatory science and healthcare-related organisations.
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